Brand Name | AMPLATZER SEPTAL OCCLUDER |
Type of Device | TRANSCATHETER SEPTAL OCCLUDER |
Manufacturer (Section D) |
AGA MEDICAL CORPORATION |
5050 nathan lane north |
plymouth MN 55442 |
|
Manufacturer (Section G) |
AGA MEDICAL CORPORATION |
5050 nathan lane north |
|
plymouth MN 55442 |
|
Manufacturer Contact |
pamela
yip
|
5050 nathan lane n |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 10890508 |
MDR Text Key | 220715725 |
Report Number | 2135147-2020-00502 |
Device Sequence Number | 1 |
Product Code |
MLV
|
UDI-Device Identifier | 00811806010076 |
UDI-Public | 00811806010076 |
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | P000039 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/23/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/31/2024 |
Device Model Number | 9-ASD-010 |
Device Catalogue Number | 9-ASD-010 |
Device Lot Number | 6935641 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/29/2020
|
Initial Date FDA Received | 11/24/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/04/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|